NCT02267733

Brief Summary

A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

October 13, 2014

Last Update Submit

August 24, 2016

Conditions

InfluenzaGammopathy

Outcome Measures

Primary Outcomes (1)

  • Rate of Disease Control

    Lack of disease progression requiring therapy as measured by International Myeloma Working Group criteria

    up to 10 months

Secondary Outcomes (5)

  • Influenza related morbidity rate

    up to 10 months

  • Serologic Protection Rate after initial vaccine

    30 days post vaccine

  • Serologic Protection Rate after initial vaccine

    30 days post booster

  • T cell response

    30 day post initial vaccine

  • T cell response

    30 day post booster

Study Arms (2)

Early Disease

EXPERIMENTAL

Patients not requiring anti-tumor therapy

Drug: Fluzone

Disease Requiring Anti-tumor therapy

EXPERIMENTAL

Patients that have disease requiring anti-tumor therapy at any time

Drug: Fluzone

Interventions

FluzoneDRUG

Fluzone High-Dose will be administered with a planned booster at 30 days post initial administration

Also known as: Fluzone High Dose
Disease Requiring Anti-tumor therapyEarly Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Understand and voluntarily sign an informed consent document
  • Age \>= 18 years at the time of signing the informed consent form
  • Diagnosis of any monoclonal gammopathy; Monoclonal Gammopathy of Undetermined Significance (MGUS), asymptomatic/ active multiple myeloma, asymptomatic / active Waldenstrom Macroglobulinemia (WM)

You may not qualify if:

  • An serious egg allergy or prior serious adverse reaction to an influenza vaccine
  • Use of any other influenza vaccine for the 2014 to 2015 flu season
  • Women who are pregnant or plan to become pregnant in the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza VaccinesFluzone High-Dose

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Andrew Branagan, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2014

First Posted

October 17, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 25, 2016

Record last verified: 2016-08

Locations

US(1)